Mild Health Care Antibacterial Hand Soap — Class II drug recall D-1316-2019
Terminated recall by Inopak Ltd, reported 2019-06-05, distributed nationwide. CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
| Recall number | D-1316-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Inopak Ltd, Ringwood, NJ, United States |
| Recall initiated | 2019-04-22 |
| Classified | 2019-05-29 |
| Reported by FDA | 2019-06-05 |
| Terminated | 2024-08-28 |
| Distributed | Nationwide (US) |
| Quantity | 17,850 pounds |
| Reason classes | cgmp |
| Lot numbers | 6656, 6959, 7008 |
Product
Mild Health Care Antibacterial Hand Soap, .6% P.C.M.X., packaged in a) 1000 ml Disc Pump pouches, 8 x 1000 ml Disc Pump pouches per case, 5013-L1000, b) 2000 ml. Disc Pump pouches, 4 x 2000 ml Disc Pump pouches per case, 5013-XL2000, c) 800 ml Universal Valve pouches, 12 x 800 ml Universal Valve pouches per case, 5013-404, d) 1 gallon bottles, 4/1 gallon bottles per case, 5013-420-02, INOPAK, LTD., 24 Executive Parkway, Ringwood, NJ 07456.
Reason for recall
CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1316-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.